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T. Akimoto
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MA 17 - Locally Advanced NSCLC (ID 671)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:S. Jheon, Georgios Stamatis
- Coordinates: 10/17/2017, 15:45 - 17:30, F203 + F204 (Annex Hall)
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MA 17.06 - Safety Data from Randomized Phase II Study of CDDP+S-1 vs CDDP+PEM Combined with TRT for Locally Advanced Non-Squamous NSCLC (ID 8296)
16:20 - 16:25 | Author(s): T. Akimoto
- Abstract
- Presentation
Background:
Both cisplatin (CDDP)+S-1 and CDDP+pemetrexed (PEM) can be given at full systemic doses with thoracic radiotherapy (TRT) in locally advanced non-small cell lung cancer (NSCLC), and CDDP+PEM is one of the standard chemotherapy regimens in patients with advanced non-squamous (non-sq) NSCLC. This multicenter, randomized, open-label, phase II study (SPECTRA) compared the efficacy and safety of the two above-mentioned promising regimens combined with TRT in patients with unresectable locally advanced non-sq NSCLC.
Method:
Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. If the 2-year PFS rate is assumed to be 25% in the inferior therapy group and 15% higher in the superior therapy group of this study, the sample size needed for selection of the optimum treatment group at a probability of approximately 95% will be 51 cases/group with the Simon’s selection design. The sample size was set at 100 patients.
Result:
Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n=17 (33%)/n=17 (34%); stage IIIB, n=21 (40%)/n=20 (40%); ECOG PS of 1, n=14 (27%)/n=14 (28%); never smoker, n=12 (23%)/n=12 (24%); and adenocarcinoma, n=47(90%)/n=45(90%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64%. Grade 3 or higher toxicities included febrile neutropenia (12%/2%), anorexia (8%/16%), diarrhea (8%/0%), esophagitis (6%/8%), pneumonia (4%/4%), neutropenia (38%/52%), anemia (8%/12%), thrombocytopenia (4%/6%), and hyponatremia (12%/12%). Grade 1 radiation pneumonitis was observed in 8 (15%)/2 (4%) patients on the basis of the data collected 30 days or less after the discontinuation of protocol treatment. No treatment-related death was observed. The data on PFS and overall survival are immature.
Conclusion:
Response rate was similar between the two arms. Toxicities were tolerable and manageable in both arms; however febrile neutropenia was more frequently observed in the CDDP+S-1 arm. We will present the updated safety data of this study at the conference. Survival data will be analyzed in late 2018.
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P2.05 - Early Stage NSCLC (ID 706)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.05-005 - Proton Beam Therapy for Early Stage Lung Cancer: A Multi-Institutional Retrospective Study in Japan (ID 9142)
09:30 - 09:30 | Author(s): T. Akimoto
- Abstract
Background:
The purpose of this study to evaluate the clinical outcome of proton beam therapy (PBT) for early stage lung cancer or small lung lesions clinically diagnosed as primary lung cancer in Japan.
Method:
Between April 2004 and December 2013, 669 patients with 682 tumors with histologically or clinically diagnosed Stage I non-small cell lung cancer (NSCLC) according to the 7th edition of UICC were treated with PBT. The medical record and imaging studies were retrospectively reviewed to analyze survivals, local control, and toxicities.
Result:
Four hundred eighty-six (72.6%) of 669 patients were men, with the median age of 76 years (range, 42 – 94 years). Tumors were distributed according to T-stage as follows: T1a (265 tumors, 38.9%), T1b (216 tumors, 31.7%), and T2a (201 tumors, 29.4%). Tumors were distributed according to histology as follows: squamous cell carcinoma (139 tumors, 20.4%), adenocarcinoma (277 tumors, 40.6%), others (32 tumors, 4.7%), and not proven (234 tumors, 34.3%). As for operability, 351 patients were found to be operable, 294 were inoperable, and 24 patients were unknown for operability. The median biological effective dose (BED) of PBT was 109.6 Gy RBE (range, 74.4 – 131.3 Gy RBE). The median follow-up time was 38.2 months (range, 0.6 – 154.5 months) for all patients. The 3-year overall survival (OS), progression-free survival (PFS), and local control were 79.5%, 64.1%, and 89.8%, respectively. Radiation pneumonitis ≥ Grade 3 according to CTCAE v3.0 was observed in 12 (1.8%) patients. The 3-year OS and PFS for 440 patients with histologically confirmed NSCLC were 78.0% (80.7% for IA, 73.0% for IB, p = 0.042) and 66.4% (71.9% for IA, 55.9% for IB, p = 0.0038), respectively. The 3-year OS and PFS for 229 patients with clinically diagnosed NSCLC were 82.4% (86.0% for IA, 60.4% for IB, p = 0.045) and 69.6% (74.0% for IA, 42.6% for IB, p = 0.0052), respectively. The 3-year OS and PFS for 351 operable patients were 86.7% (88.8% for IA, 80.3% for IB, p = 0.096) and 70.6% (76.4% for IA, 52.8% for IB, p = 0.0028), respectively. The 3-year OS and PFS for 294 inoperable patients were 70.5% (74.1% for IA, 62.8% for IB, p = 0.046) and 56.6% (62.6% for IA, 44.6% for IB, p = 0.0062), respectively.
Conclusion:
PBT for early stage lung cancer is an effective treatment option with low incidence of severe radiation pneumonitis.
